ATLANTA, March 14 /PRNewswire-FirstCall/ -- GeoVax Inc., an Atlanta, Georgia biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus - AIDS) and other infectious agents, today announced that the FDA [Food & Drug Administration] granted “Safe to Proceed” status to an “Investigational New Drug” [IND] application to conduct human clinical trials with GeoVax AIDS vaccines.
These human trials will administer 2 doses of our DNA vaccine to prime the immune response followed by 2 doses of our recombinant MVA vaccine to boost the immune response. Both AIDS vaccines are genetically engineered to express key AIDS virus proteins.
Human trials will first evaluate the safety and immune responses [indicative of potential protection against AIDS] induced by low doses of our DNA and recombinant MVA vaccines and then evaluate the safety and immune responses induced by high doses of these DNA and MVA vaccines.
The trial sites requesting approval to open the study include the University of Alabama in Birmingham, Saint Louis University, and the University of Maryland through the HVTN [HIV Vaccine Trials Network] which is funded and supported by the US NIAID [National Institute of Allergy and Infectious Disease].
Human trials testing the GeoVax HIV/AIDS vaccines are anticipated to begin in April 2006.
Note: Prototype GeoVax DNA and MVA HIV/AIDS vaccines previously demonstrated safety as well as effectiveness in preventing clinical signs of AIDS in 22 of 23 [96% protection] non-human primates for over 3 1/2 years while 5 of 6 non-vaccinated monkeys developed AIDS within 8 months post-AIDS virus infection.
This FDA “Safe to Proceed” status is a key step forward in testing and evaluating our DNA/MVA AIDS vaccines for their safety and protective potential in humans.
About GeoVax Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus - AIDS) and other infectious agents. Present goals include: developing AIDS vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions (FDA guidelines), conducting human trials for vaccine safety and effectiveness and obtaining regulatory approval of these vaccines in the USA and international markets. Global market estimates exceed $4 billion for effective and safe AIDS vaccines.
GeoVax Inc. recently signed an AGREEMENT AND PLAN OF MERGER with Dauphin Technology, Inc. with GeoVax the proposed surviving company controlling 67% of newly issued and outstanding stock and receiving additional operating capital.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop vaccines with the desired characteristics in a timely manner, GeoVax’s vaccines will be determined to be safe for use in humans, GeoVax’s vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so.
GeoVax Inc.
CONTACT: Don Hildebrand of GeoVax Inc., +1-404-727-0971